BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1030853 · Received April 17, 2008

    Report

    Report Number
    3004209178-2008-02035
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERSTIM II PATIENT HAD A TINGLING SENSATION IN HER LEGS AFTER HER STIMULATOR WAS TURNED OFF. REPROGRAMMING TRIALS WERE PERFORMED; THE PT EXPERIENCED OVERSTIMULATION AND NEW PAIN. THE HCP WAS UNABLE TO PROVIDE OUTCOME DUE TO THE REPROGRAMMING BEING TOO NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| LEAD MODEL 3889